510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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QBXClass II

Direct Blood Bacterial Nucleic Acid Detection System

21 CFR 866.3960 / Microbiology
FDA source (opens on fda.gov)

QBX is the FDA product code for Direct Blood Bacterial Nucleic Acid Detection System, a class II device type, regulated under 21 CFR 866.3960. FDA's definition for this code reads: "Amplification, detection and identification of microbial pathogens directly from whole blood specimens". As of , FDA records hold 2 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
QBX
Device name
Direct Blood Bacterial Nucleic Acid Detection System
FDA definition
Amplification, detection and identification of microbial pathogens directly from whole blood specimens
Regulation
21 CFR 866.3960
Device class
Class II
Review panel
Microbiology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
2
Ingested recalls
0

Clearances, product code QBX

By decision year
2 clearances under product code QBX with a decision year between 2018 and 2024, 2018 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code QBX by decision year
YearClearances
20181
20241

Applicants with the most clearances

Product code QBX
Applicants holding the most 510(k) clearances under product code QBX
ApplicantClearances
T2biosystems, Inc.2

Companies listing this code with FDA

Companies whose registered establishments list this code

No registered establishment in MDM’s records lists product code QBX.